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Design Controls FDA Small Business

Regulatory Education for Industry (REdI) Bethesda, Maryland September 18, 2014

Stanley Liu Consumer Safety Officer

Office of Communication and Education Center for Devices and Radiological Health

U.S. Food and Drug Administration

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Overview I. Introduction to Design Controls

II. Requirements for Design Controls

1. Design planning 2. Design input and output 3. Design review 4. Design verification and validation 5. Design changes 6. Design transfer 7. Design history file

III. Resources and FDA contacts

I. Introduction to Design Controls

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Design Controls – What are they?

• A set of quality practices and procedures incorporated into the design and development process

• Control the design process to assure that device specifications meet:

−User needs − Intended use

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Design Controls – Why? • 44% of voluntary recalls from October 1983 through

September 1989 - may have been prevented by adequate design controls. Source: ‘‘Device Recalls: A Study of Quality Problems’’ (see 55 FR 21108, May 22, 1990) and “QS Regulations (Final Rule)” (see 61 FR 52602, October 07, 1996)

• 90% of all software related device failures from 1983 through 1989 were due to design related error. Source: “FDA Medical Device Regulation from Premarket Review to Recall” (FDA/HHS OEI 09-90-0040, February 1991)

• Most frequent causes for recalls related to Design, Software, and Non-Conforming Materials/Components. Source: “Medical Recall Report FY2003 to FY2012” (CDRH Office of Compliance, Division of Analysis and Program Operations)

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Design Controls- Regulatory History

• Safe Medical Device Act of 1990 authorized FDA to add Design Controls to the current Good Manufacturing Practice (cGMP) requirements for devices.

• The QS Regulation became effective on June 1, 1997,

replacing the 1978 GMP for medical devices. • Preamble to the QS regulation: extremely important for

understanding Design Controls.

Quality Systems - Key Definitions

• Design History File (DHF) - compilation of records which describes the design history of a finished device.

• Device Master Record (DMR) - compilation of records containing the procedures and specifications for a finished device.

• Device History Record (DHR) - compilation of records containing the production history of a finished device.

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Design Controls – Scope

• Design controls apply to: – All Class II and Class III devices – The following Class I devices:

1. Devices automated with computer software 2. Tracheobronchial suction catheters 3. Surgeon's gloves 4. Protective restraints 5. Manual radionuclide applicator system 6. Radionuclide teletherapy source

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Design Controls

• Design control is a Key Subsystem of Quality System • Quality System (QS) Regulations: 21CFR 820

– Management controls – Design controls – Production and process controls – Corrective and preventive actions – Documents, Records, & Change Control – Material Control – Facility & Equipment Control

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Design Controls

• Incorporates Quality System of Risk Management and Analysis: – Systematic application of management policies, procedures,

practices, insight/judgment, and experience for identifying, analyzing, controlling, and monitoring risk.

– Risk Management and Analysis are integrated into the Design Control process.

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7 Subsystems of the Quality System

Design Control

Material Control Documents,

Records & Change Control

Facility & Equipment

Control

Production & Process Control

Corrective & Preventive

Action Control

Management Control

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Design Controls (21 CFR 820.30)

a) General requirements b) Design and development planning c) Design input d) Design output e) Design review f) Design verification g) Design validation h) Design changes i) Design transfer j) Design history file

II. Requirements for Design Controls

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General Requirements

21CFR 820.30(a)

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Design Controls – General

• Establish procedures to control device design: – Define

– Document

– Implement

• Maintain procedures to control device design: – Review

– Approve

– Update

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Design and Development Planning

21CFR 820.30(b)

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Design & Development Planning

• Establish, maintain and document Planning:

– Describe or reference design and development activities.

– Identify, describe, and define interfaces, responsibilities, and activities impacting device design.

– Review, document, approve, and update as developments and changes evolve.

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Design Input

21CFR 820.30(c)

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Definition

• Design inputs mean the physical and performance characteristics of a device that are used as a bases for device design.

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Design Input

• Establish and maintain procedures for design input:

– Ensure requirements are appropriate by addressing user needs and intended use in terms that are measurable

– Address incomplete, ambiguous, or conflicting requirements

– Document, review, and approve input requirements

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Sources of Design Input

• Standards • Focus groups • Customers • MDRs • CAPA

• Service reports • Complaints • Marketing surveys • Sales feedback • Competitors’ products

Including input from earlier/previous versions of a device

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Examples of Design Input

• Device functions • Physical characteristics • Performance • Safety • Reliability • Standards • Regulatory

requirements

• Human factors • Labeling & packaging • Maintenance • Sterilization • Compatibility with other

devices • Environmental limits

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Example Infusion Pump

Issue /Risk: • Infusion pump stops operating when high-

voltage medical devices are operating in the vicinity.

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Example – Questions to Consider

• What are the user needs? • In what environment is the infusion pump

supposed to function? • What other kinds of equipment will it be used

with? • What kinds of design input are needed to avoid

this problem?

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Example - Infusion Pump

User Need Pump must be capable of functioning in an electromagnetic environment (e.g., hospital).

Design Input Pump must function uninterrupted when used with other products that generate an electromagnetic field.

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Design Output

21CFR 820.30(d)

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Definition

• Design outputs mean the results of a design effort at each design phase and at the end of the total design effort.

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Design Output • Establish and maintain procedures for

design output: – Define and document design output in terms that allow an

adequate evaluation of conformance to design input.

– Reference acceptance criteria (i.e., criteria that are definable, and measurable).

– Identify design outputs essential for the proper functioning of the device.

– Review and approve design output before release.

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In other words...

• Design outputs are the design specifications which must meet design input requirements, as confirmed during design Verification and Validation and ensured during design Review (more later).

Input Output

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Design Output

• Design Outputs are included in premarket submissions as Device Specifications.

• The finished design output is the basis for the Device Master Record (DMR).

• The total finished design output consists of the device, its packaging, labeling, and the Device Master Record (DMR).

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User Need Pump must be capable of functioning in an electromagnetic environment (e.g., hospital).

Design Input Pump must function uninterrupted when used with other products that generate an electromagnetic field.

Design Output

•Circuit board with filtering or buffering circuit

•Pump EMI shield

•Software with signal filtering and error handling/correcting code

Example - Infusion Pump

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Design Review

21CFR 820.30(e)

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Design Review

• Design Review means a documented, comprehensive, systematic examination to:

– Evaluate adequacy of the design requirements. – Evaluate capability of the design to meet requirements. – Identify any problems.

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Design Review

• Establish and maintain procedures.

• Plan and conduct formal documented Design Reviews of design results at appropriate stages.

• Include at each design review: – Representatives of all functions concerned and specialists as

needed. – Individual(s) without direct responsibility for the stage being

reviewed.

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Design Review

• Document results of design review in Design History File (DHF), including:

– Identification of design

– Date

– Individuals performing review

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Design Verification

21CFR 820.30(f)

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Definition • Verification means confirmation by

examination and provision of objective evidence that output meets input requirements.

Input = Output

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Design Verification

• Establish and maintain procedures for Design Verification:

– Confirm through measurable means (e.g., test reports, etc.).

– Review, approve and document in Design History File (DHF).

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Design Verification

• Many test reports associated with Design Verification are included in premarket submissions:

– 510(k)s – de novos – Premarket Approval Applications (PMAs) – Investigational Device Exemptions (IDEs)

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Example - Infusion Pump

User Need

Pump must function in an operating room environment.

Design Input Pump must function uninterrupted when used with other products that generate an electromagnetic field.

Design Output

•PCB with filtering circuit

•Pump EMI shield

•Software signal filtering code and error handling code

Design Verification

•Simulated EMI testing on hardware and software

•Dimensional verification of shield

•Verification of system error handling due to EMI

Design Review

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Design Validation

21CFR 820.30(g)

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Definition • Design Validation means establishing

by objective evidence that specifications(specified requirements) conform with user needs and intended use(s).

Specifications= user needs

intended use(s)

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Design Validation

• Establish and maintain procedures for Design Validation: – Under defined operating conditions. – On initial production units, lots, or batches (or their

equivalents). – Under actual or simulated use conditions.

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Design Validation

• Perform software validation and risk analysis, where appropriate.

• Review, approve, and document in Design History File.

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Verification vs. Validation

• Design Verification – Output meets Input – “Did I make the product correctly?”

• Design Validation – Specifications meets user needs and intended use(s) – “Did I make the correct product?”

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Design Validation

• The results of Design Validation are typically submitted in premarket submissions.

• Examples: – Animal study protocols/reports – Cadaver study protocols/reports – Clinical study protocols/reports

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User Need

Pump must function in an operating room environment.

Design Input Pump must function uninterrupted when used with other products that generate an electromagnetic field.

Design Output

•PCB with filtering circuit

•Pump EMI shield

•Software signal filtering code and error handling code

Design Verification

•Simulated EMI testing on hardware and software

•Dimensional verification of shield

•Verification of system error handling due to EMI

Design Validation

•EMC testing to industry standards

•Simulated EMI testing in high EMI environment

•Risk Analysis concerning EMI

•Software validation for filtering code

Design Review

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Warning Letter Example

Failure to establish and maintain adequate procedures for Validating the device design and Risk Analysis, where appropriate, as required by 21 CFR 820.30(g)

For example: The Design History Files for XXX did not include documentation that the device had ever been validated before production and marketing. When requested, the firm was unable to provide documentation that validation and risk analysis had been performed.

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Design Transfer

21CFR 812.30(h)

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Design Transfer • Establish and maintain procedures to ensure

correct Design Transfer into production specifications.

• Is the Design accurately transferred to Production?

• Although Design Transfer happens throughout, there frequently is a final stage of development intended to ensure all outputs are adequately transferred.

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Design Changes

21CFR 820.30(i)

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Design Changes • Establish and maintain procedures for the

identification, documentation, validation or where appropriate verification, review, and approval of Design Changes before their implementation.

• Is there a system in place to enact future changes?

• Often overlooked, but of critically importance. • How can you improve your product if you

have no system for change?

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Design Changes

• Depending on the scope and impact of the change, the change may require: – A new 510(k) – A new PMA, a PMA supplement, or a PMA 30-Day Notice – A new IDE or an IDE supplement

• Changes must be communicated to FDA if the device is under premarket review or IDE review.

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Design History File

21CFR 820.30(j)

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Definition

• Design History File (DHF) means a compilation of records which describes the design history of a finished device.

• It is a summation record of all Design actions, from start to transfer, including changes.

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Design History File

• Establish and maintain a design history file for each type of device

• Include in the DHF, or reference records information necessary to demonstrate that the design was developed in accordance with the Design Plan and Quality Systems requirements

Design Controls - Summary

• Like the Quality Systems regulations themselves, Design Control should be viewed and understood as a system – a subsystem within the main Quality System.

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Design Controls - Summary • Processes –A set of quality practices and procedures

incorporated into the design and development process

• Goal - Control the design process to assure that device specifications meet: – User needs – Intended use

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III. Resources and FDA Contacts

• CDRH Learn Training videos focusing on overview, premarket,

registration/listing, and post-market topics http://www.fda.gov/Training/CDRHLearn/default.htm

• Device Advice Website accompaniment to CDRH Learn

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm

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QS Regulation and Guidance (General)

• Quality System Regulation and Preamble http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/ucm230127.htm

• Design Control Guidance For Medical Device Manufacturers

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070627.htm

• Do it By Design – An Introduction to Human Factors in Medical Devices

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM095061.pdf

• Guidance for Industry and FDA Premarket and Design Control Reviewers –

Medical Device Use – Safety: Incorporating Human Factors Engineering into Risk Management http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM094461.pdf

• (DRAFT) Applying Human Factors and Usability Engineering to Optimize Medical Device Design http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm259748.htm

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QS Regulation and Guidance

• Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope and Application http://www.fda.gov/RegulatoryInformation/Guidances/ucm125067.htm

• General Principles of Software Validation

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085281.htm

• Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm

• Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf

Software Use in Medical Devices http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073778.htm

• Guidance: Mobile Medical Applications http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm263366.pdf

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Need More Information?

Division of Industry and Consumer Education (DICE)

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ContactUs--

DivisionofIndustryandConsumerEducation/default.htm

• Email: DICE@fda.hhs.gov • Phone: 301-796-7100 or 800-638-2041